ENT EM is an AI-enabled medical device from Brainlab AG, listed by FDA (510(k), K223734) with a decision date of 2023-04-27. Review panel: Neurology.
| FDA submission number | K223734 |
|---|---|
| Pathway | 510(k) |
| Company | Brainlab AG |
| Review panel (specialty) | Neurology |
| FDA decision date | 2023-04-27 |
| Decision | Substantially Equivalent |
| Product code | PGW |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Device class | 2 |
| Regulation number | 882.4560 |
| Review time (calendar days) | 135 |
| Applicant country | DE |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.